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Brasseler USA I Recalls
3 recalls on record · December 11, 2019 to February 14, 2024 · Medical Devices
Recalls by year
19
20
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 14, 2024Medical DevicesFDA
Brasseler USA I Lp recalls Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Hazard: The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
February 5, 2020Medical DevicesFDA
Brasseler USA I Lp recalls Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Stein
Hazard: 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins.
December 11, 2019Medical DevicesFDA
Brasseler USA I Lp recalls BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product U
Hazard: One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.